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Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically proven squamous cell carcinoma.
  2. Tumours are located in the thoracic oesophagus.
  3. Age is between 18 years and 70 years.
  4. ECOG performance status of 0 or 1.
  5. Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
  6. No metastatic cervical lymph nodes.
  7. R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection.
  8. No prior therapy was administered against other cancers.
  9. Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
  10. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard).
  11. Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
  12. Normal thyroid function.
  13. Written consent is obtained.

Exclusion Criteria:

  1. Patients receive neoadjuvant chemoradiation therapy.
  2. Patients with pathological complete response (pCR).
  3. No. of lymph node dissection < 15.
  4. Patients with clinical stages T1-2N+M0 and receive upfront surgery.
  5. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
  6. Patients requiring systemic steroid medication.
  7. Patients with severe postoperative complications and not suitable for adjuvant therapy.
  8. Synchronous or metachronous (within 5 years) double cancers.
  9. Patients ever received immunotherapy.
  10. Active infection requiring systemic therapy.
  11. Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
  12. Patients with human immunodeficiency virus (HIV) infection.
  13. Psychiatric disease.
  14. Pregnant or lactating women or women of childbearing potential.
  15. Hypersensitivity for Sintilimab.

Sites / Locations

  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant Arm

Observation Arm

Arm Description

Patients in arm A receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.

Patients in observation arm receive routine follow-up after surgery.

Outcomes

Primary Outcome Measures

Disease-free Survival (DFS)
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
August 8, 2022
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05495152
Brief Title
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
Official Title
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: A Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Arm
Arm Type
Experimental
Arm Description
Patients in arm A receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.
Arm Title
Observation Arm
Arm Type
No Intervention
Arm Description
Patients in observation arm receive routine follow-up after surgery.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Patients in adjuvant arm receive 17 cycles of Sintilimab within 4 to 12 weeks after esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks.
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.
Time Frame
DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven squamous cell carcinoma. Tumours are located in the thoracic oesophagus. Age is between 18 years and 70 years. ECOG performance status of 0 or 1. Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery. No metastatic cervical lymph nodes. R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection. No prior therapy was administered against other cancers. Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard). Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula. Normal thyroid function. Written consent is obtained. Exclusion Criteria: Patients receive neoadjuvant chemoradiation therapy. Patients with pathological complete response (pCR). No. of lymph node dissection < 15. Patients with clinical stages T1-2N+M0 and receive upfront surgery. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy. Patients requiring systemic steroid medication. Patients with severe postoperative complications and not suitable for adjuvant therapy. Synchronous or metachronous (within 5 years) double cancers. Patients ever received immunotherapy. Active infection requiring systemic therapy. Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation. Patients with human immunodeficiency virus (HIV) infection. Psychiatric disease. Pregnant or lactating women or women of childbearing potential. Hypersensitivity for Sintilimab.
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

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